The Hunter Humira and Endothelial Function in Early Rheumatoid Arthritis Trial

Phase 2

Completed

• Conditions: Rheumatoid Arthritis; Cardiovascular Disease; Musculoskeletal - Other muscular and skeletal disorders; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12611000972921
• Lead Sponsor: A/Prof Stephen Oakley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-12
• Study Completion: 2016-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Group 1: Early Rheumatoid Arthritis: Anti-CCP (ACPA) positive rheumatoid arthritis of less than 1 year duration by onset of symptoms, age over 18 years, CRP > 15 mg/L or DAS28-CRP>3.20 within 1 week of enrolment.

Group 2: Established Rheumatoid Arthritis: Anti-CCP (ACPA) positive rheumatoid arthritis of greater than 1 year duration by onset of symptoms, age over 18 years, CRP>15 mg/L or DAS28-CRP>3.20 within one month of enrolment

Exclusion Criteria

1. Disease Remission (ACR / EULAR 2010 Criteria) or CRP<15 mg/L
2. Anti-CCP antibody test negative
3. Serious malignancy within the last 5 years
4. Demyelinating Disease
5. Evidence of previous untreated TB infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EndoPAT assessments of endothelial function[Minus 2 weeks, Baseline, 4 weeks, 12 weeks, 24 weeks, and an additional assessment will be performed between weeks 36 and 48, 12 weeks after completion of the blinded phase of the study. ]